MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Model Number	400SMTSFT0304
Medical Device Problem Codes	Failure to Fold (1255); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 1.3005168196-2020-00457.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It was reported that the patient anatomy was tortuous.During the procedure, while attempting to advance the smart coil into the aneurysm, the physician had difficulty and the smart coil kicked the microcatheter out of the aneurysm.Subsequently, the physician was able to successfully place the smart coil in the aneurysm.The physician then had difficulty while attempting to advance the next smart coil into the aneurysm; therefore, the physician re-sheathed the smart coil then removed the microcatheter.Next, the physician placed another microcatheter and attempted to advance the same smart coil into the aneurysm; however, the smart coil kicked the microcatheter out of the aneurysm.It was also reported that the smart coil did not take its intended shape; therefore, it was removed.The procedure was completed using two other coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra distributor on 05/08/2020: the manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2020-00457.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It was reported that the patient anatomy was tortuous.During the procedure, while attempting to advance the smart coil into the aneurysm, the physician had difficulty and the smart coil kicked the microcatheter out of the aneurysm.Subsequently, the physician was able to successfully place the smart coil in the aneurysm.The physician then had difficulty while attempting to advance the next smart coil into the aneurysm; therefore, the physician re-sheathed the smart coil then removed the microcatheter.Next, the physician placed another microcatheter and attempted to advance the same smart coil into the aneurysm; however, the smart coil kicked the microcatheter out of the aneurysm.It was also reported that the smart coil did not take its intended shape; therefore, it was removed.The procedure was completed using two other coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9892179
• Report Number: 3005168196-2020-00458
• Device Sequence Number: 16749305
• Product Code: HCG
• UDI-Device Identifier: 00814548015033
• UDI-Public: 00814548015033
• Combination Product (Y/N): Y
• Initial Reporter Country: CS
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2019
• Device Model Number: 400SMTSFT0304
• Device Catalogue Number: 400SMTSFT0304
• Device Lot Number: F88981
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005